A randomised, double-blind, negatively-controlled study to determine whether the use of creams or ointments could alter the sensitivity of the skin to ultraviolet light during photo-therapy with narrow band UVB
| ISRCTN | ISRCTN25782645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25782645 |
| Protocol serial number | N0547127254 |
| Sponsor | Department of Health |
| Funder | East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 01/11/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Eunice Tan
Scientific
Scientific
Department of Dermatology
Norfolk and Norwich University Hospital NHS Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, negatively-controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Do creams or ointments applied before irradiation of the skin with narrow band UVB impair or improve the transmission of ultraviolet radiation to the skin? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Not Applicable: Phototherapy |
| Intervention | Creams or ointments applied before irradiation vs standard practice |
| Intervention type | Other |
| Primary outcome measure(s) |
Determination of MED in each subject for each topical agent at 24 hours after narrow band UVB exposure. |
| Key secondary outcome measure(s) |
Adverse events: pain, blistering, hyperpigmentary changes. |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 03/03/2003 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Dermatology
Norwich
NR4 7UY
United Kingdom
NR4 7UY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2011 | Yes | No |
